Analysis of the Clinical and Histological Correlation of Oral Graft-Versus-Host-Disease (GVHD) (ORALGVHD)

May 11, 2009 updated by: University of Sao Paulo

Clinical and Histological Evaluation of Chronic Graft-Versus Host Disease (cGVHD) in Oral Mucosa

Introduction: Graft-versus-host-disease (GVHD) is the major cause of morbidity and mortality in patients submitted to the Bone Marrow Transplantation (BMT). The oral manifestations can be very debilitating and interfere in the results of medical therapy, leading to systemic complications, committing the prognosis and quality of life of the patient.

The early diagnosis can be done through biopsies of oral mucosa with or without apparent injury clinic. The association between the clinical and histopathological tables of GVHD, especially through the use of recent consensus established in these areas, can bring new benefits to physicians.

Objective: This study aims to apply and compare the two classifications histological to GVHD, Horn (1995) and Consensus (2006) in specimens obtained from clinical oral lesions suggestive of GVHD; correlate them with clinical classification according Akpek (2001) and with the survival of the patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: For this study we analyzed histological samples of oral mucosa of 10 patients with clinical diagnosis of GVHD, which have areas of epithelium, and salivary gland. The histopathological aspects were observed by the author of this work and his advisor, so blinded by applying the criteria for Horn and the Consensus. We consistency between the two classifications obtained and histological correlation with the clinical classification of GVHD (Akpek, 2001) and the curve of survival.

Study Type

Observational

Enrollment (Actual)

41

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients underwent bone marrow transplantation with clinical signs of oral Graft-versus-host Disease

Description

Inclusion Criteria:

  • all patients with clinical signs of oral GVHD that underwent oral biopsy

Exclusion Criteria:

  • samples without epithelium or minor salivary glands

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bone Marrow Transplantation
Procedure: oral biopsy
oral mucosa and salivary gland biopsy after bone marrow transplantation
Other Names:
  • bone marrow transplantation
  • oral manifestations
  • graft-versus-host disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The histological classification according Horn showed that in most cases there was presence of GVHD with low degrees of severity; Already classification of the Consensus showed that there were in full presence of GVHD of moderate degree.
Time Frame: during the survey data, and analysis of specimens
during the survey data, and analysis of specimens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Marina HG Magalhães, DMD, PhD, University of Sao Paulo - Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

May 12, 2009

Last Update Submitted That Met QC Criteria

May 11, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPPSSS1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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